Stand alone intervertebral fusion device

ABSTRACT

An angled fixation device, such as an angled screw. This angled fixation device may be used by the surgeon to secure a spacer to a spinal disc space. The proximal end portion of the angled fixation device is driven perpendicular to the anterior wall of the spacer, and so is parallel to the vertebral endplates and in-line with the inserter. The distal end portion of the angled fixation device is oriented at about a 45 degree angle (plus or minus 30 degrees) to the vertebral endplate it enters.

CONTINUING DATA

This is a divisional patent application of U.S. Ser. No. 13/237,233,filed Sep. 20, 2011, which claims priority from U.S. Ser. No.61/385,959, filed Sep. 23, 2010, the specification of each of which isincorporated by reference in its entirety.

U.S. Ser. No. 13/237,233, filed Sep. 20, 2011, further claims priorityfrom U.S. Ser. No. 61/466,309, filed Mar. 22, 2011, and entitled “NovelImplant Inserter Having a Laterally-Extending Dovetail EngagementFeature,” the specification of which is incorporated by reference in itsentirety. Ser. No. 13/237,233, filed Sep. 20, 2011, is related to U.S.Ser. No. 13/237,200 filed Sep. 20, 2011, entitled “Novel ImplantInserter Having a Laterally-Extending Dovetail Engagement Feature,” thespecification of which is incorporated by reference in its entirety.

U.S. Ser. No. 13/237,233, filed Sep. 20, 2011, further claims priorityfrom U.S. Ser. No. 61/466,321, filed Mar. 22, 2011, and entitled “FusionCage with In-Line Single Piece Fixation,” the specification of which isincorporated by reference in its entirety. U.S. Ser. No. 13/237,233,filed Sep. 20, 2011, is related to U.S. Ser. No. 13/237,174, filed Sep.20, 2011, entitled “Fusion Cage with In-Line Single Piece Fixation,” thespecification of which is incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

During cervical spinal surgery for the fusion of an intervertebral disc,an anterior approach, discectomy and insertion of a spacer/cage areoften performed. However, in these situations, the spine surgeon oftenprefers not to insert a plate on the anterior surface of the disc spacewith fixation through the anterior face of the cephalaud and caudalvertebral bodies. This reluctance stems from the observation that theanterior plate can be situated too proud and so its profile cansometimes cause patient discomfort and cause dysphasia and/or dysphonia.

In some fusion cases using a stand alone spacer, the surgeon must inserta fixation device (such as a screw) into the spacer at a sharp anglethrough sometimes challenging approaches. This can be especiallydifficult for the cervical spine, as the surgeon needs to either deliverthe screw down into the inferior vertebral body but may be obstructed bythe patient's chin, or deliver the screw up into the superior vertebralbody but may be obstructed by the patient's sternum.

U.S. Pat. No. 7,135,043 (Nakahara) discloses an intervertebral cagecomprising regulated insertion direction ridges. The cage may include amain body defined by an upper surface, a lower surface, and a pair ofside surfaces. A withdrawal prevention portion is provided on the upperand/or the lower surfaces of the main body and asymmetrically withrespect to the side surfaces in a top or bottom plan view. Thewithdrawal prevention portion regulates an insertion direction of theintervertebral cage. The portion of the Nakahara device that holds thescrews does not possess teeth upon its upper and lower surfaces.

U.S. Patent Publication No. 2007-0250167 (“Bray”) discloses a device forthe fixation and support of bone bodies includes a base member forimplantation into a patient at a location between two bone bodies. Thebase member of the device includes an enclosed chamber for receivingfusion material and apertures for receiving bone fasteners that can beembedded into the adjacent bone bodies. The device further includesprotrusions extending from the base member, wherein the protrusions areconfigured for engagement with one or more bone bodies upon implantationand for progressive penetration into at least one bone body over aperiod of time subsequent to the implantation. However, the faceplatethat holds the screws is not designed to be implanted in the disc space,but rather cloaks the anterior wall of the upper vertebral body.

The Globus Coalition Cage has protrusions that begin from the anteriorface, and upon insertion, displace bone from the anterior face throughthe desired depth in a track formation rather than penetrating fromwithin the space.

U.S. Pat. No. 7,232,464 (Mathieu) discloses an intervertebral implant inthe form of a three-dimensional structure comprising (a) a top side andan underside that are designed to rest against the end plates of twoadjacent vertebras, (b) a left side face and a right side face, (c) afront face and a rear face, (d) a horizontal center plane situatedbetween the top side and the underside, (e) a vertical center planesituated between the left side face and the right side face and (f) aplurality of boreholes passing through the implant structure that aredesigned to receive longitudinal affixation elements, the axes of saidelements intersecting the horizontal center plane. At least one of theboreholes is designed in a manner that the affixation element receivedin it can be rigidly connected to the intervertebral implant. Theconnection is implemented using a thread or by matching conicalsurfaces.

U.S. Patent Publication No. 2008-0306596 (“Jones”) discloses a methodand apparatus for use in spinal fusion procedures. An interbody fusiondevice has a first piece that is a load bearing device designed to bearthe axial loading from the end plates of adjacent vertebrae. A secondpiece of the interbody fusion device is a retention device whosefunction is to prevent migration of the load bearing device. One or morefasteners secure the retention device to the vertebrae above and belowthe load bearing device. The fasteners cause the end plates of thevertebrae to compress the end plates to the load bearing device tofacilitate proper fusion.

U.S. Patent Publication No. 2008-0249625 (Waugh) discloses a compositeinterbody spacer includes a first portion (such as a faceplate) formedof a first material and a second portion (such as a cage) formed of asecond material.

U.S. Patent Publication No. 2008-0249575 (“Waugh”) discloses a standalone fusion cage in which the apertures that receive the bone anchorshave an integral locking ring formed therein.

PCT Published Patent Application WO 02/13732 (“Bramlet”) discloses anapparatus and method for fusing opposing spinal vertebrae. In anembodiment for a spinal implant of the present invention, the implantincludes a body assembly and a retention member coupled to the bodyassembly. The retention member includes a tang where the tang isextendible from the body assembly. In a method of the present invention,the method includes the step of inserting an implant between adjacentvertebrae with a retention member of the implant in a first retractedconfiguration. The method also includes the step of configuring theretention member in a second extended configuration wherein theretention member is in its second extended configuration, a portion of atang of the retention member extends from the implant and into one ofthe adjacent vertebrae.

U.S. Pat. No. 6,336,928 (“DePuy France”) discloses a device for joiningat least two vertebral bodies, which comprises at least one plateequipped at each end with anchoring parts which can be introducedsubstantially vertically into seats previously established in thevertebral bodies to be joined, and then, after introduction, can befolded back at an angle towards one another in order to exert a constantcompression of the vertebral bodies and to ensure perfect anchoring,wherein each anchoring part is connected to the ends of thecorresponding plate via a central connection zone delimiting twoprofiled notches in order to permit deformation of the zone, in such away that each pair of anchoring parts permits a compression, both at thelevel of the plate and at the level of its ends, and in such a way thatthe anchoring parts at each end of the plate permit a clamping whichprevents any extraction.

U.S. Pat. No. 6,773,437 (“Ogilvie”) discloses a fusionless method ofcorrecting spinal deformities in growing adolescents is disclosedutilizing a shape memory alloy staple. Various embodiments of the shapememory alloy staple include features such as barbs on the inner andouter surfaces of the prongs in the shape memory alloy staple as well asthe use of notches on the crossbar or cross plate connecting the prongsto the shape memory alloy staple. In some embodiments, the shape memoryalloy staple has an aperture defined through the cross plate forreceiving a bone screw or other bone anchor which in turn allows theinterconnection of a longitudinal member.

U.S. Pat. No. 7,594,931 (“LDR I”) discloses an intervertebralarthrodesis for insertion in an intervertebral space separating oppositefaces of two adjacent vertebrae has a ring shaped intervertebral cagehaving a bar that extends perpendicular to the axis of the spine. Thebar has a height less than the rest of the cage. A surface of the cagecontacting the vertebrae has an undulating shape for limiting sliding ofthe cage in a plane parallel to the vertebrae faces.

PCT Published Patent Application WO 2008/149223 (“LDR II”) discloses anintersomatic cage, an intervertebral prosthesis, an anchoring device andan instrument for implantation of the cage or the prosthesis and theanchoring device, as well as a system and a method for implanting spinalimplants and anchoring devices in vertebrae. An intersomatic cage or anintervertebral prosthesis fit closely to the anchoring device, whichincludes a body of elongated shape on a longitudinal axis, of curvedshape describing, along the longitudinal axis, an arc whose dimensionsand radius of curvature are designed in such a manner that the anchoringdevice may be implanted in the vertebral plate of a vertebra bypresenting its longitudinal axis substantially along the plane of theintervertebral space, where the anchoring device is inserted, by meansof the instrument, through a slot located in at least one peripheralwall of the cage or on at least one plate of the intervertebral discprosthesis to penetrate into at least one vertebral plate

PCT Published Patent Application WO-2010/028045 (“Lawton”) discloses anintervertebral implant for insertion into an intervertebral disc spacebetween adjacent vertebral bodies or between two bone portions. Theimplant includes a spacer portion, a plate portion operatively coupledto the spacer portion and one or more blades for securing the implant tothe adjacent vertebral bodies. The blades preferably include superiorand inferior cylindrical pins for engaging the adjacent vertebralbodies. The implant may be configured to be inserted via a directlateral transposals approach. Alternatively, the implant may beconfigured for insertion via an anterior approach.

U.S. Published Patent Application 2005-0149192 (“Zucherman I”) disclosesan intervertebral implant has a fusion body with at least one keel thatanchors the implant into cancellous bone of at least one vertebral body.A method for implantation includes lateral implantation of the implant.

U.S. Published Patent Application 2005-0149193 (“Zucherman II”)discloses an intervertebral implant has a fusion body with at least onekeel that anchors the implant into cancellous bone of at least onevertebral body. A method for implantation includes lateral implantationof the implant.

U.S. Published Patent Application 2004-0260286 (“Ferree”) discloses anintradiscal components associated with Total Disc Replacements (TDRs),for example, are maintained in a disc space with keels having attributesthat resist extrusion, pull-out, and/or backout. In the preferredembodiment, the keel is curved to resist extrusion, particularlyanterior or posterior extrusion. The invention may include a TDR with apair of endplates, each with a keel extending into a different vertebralbody, and wherein the keels are angled or curved in different directionsto resist extrusion. In alternative embodiments, the keel may includeone or more members that extend outwardly to resist extrusion. Suchmembers may be spring-biased, composed of a shape-memory material, orextend outwardly in response to an applied mechanical force, as might beapplied by turning a screw. The keel may further include a bone-ingrowthplug or coating or ‘teeth’ to resist extrusion. Keels according to theinvention may also be configured to resist extrusion through theaddition of an elongate member that penetrates a vertebral body and thekeel. Such a member may be a secondary keel or screw.

U.S. Published Patent Application 2008-0167666 (“Fiere”) disclosesequipment including at least one U-shaped clip whose lateral brancheshave sections and widths such that they may be inserted in the vertebralbodies of two vertebrae by impaction on the intermediate branch of theclip, so as to rest along the cortical bones of the vertebral bodies,and whose intermediate branch is deformable in such a way as to allow areduction of the distance between the lateral branches; the intermediatebranch, before implantation, has a length such that one of the lateralbranches may be positioned slightly above the cortical bone forming theplate of the subjacent vertebra while the other lateral branch may bepositioned slightly below the cortical bone forming the plate of thesubjacent vertebra, and has, after deformation, a length such that thetwo lateral branches may be brought closer to each other.

U.S. Published Patent Application 2010-0004747 (“Lin”) discloses atrans-vertebral and intra-vertebral plate and a rectangular cage with aslot for the plate of spinal fixation device are for neutralizingintervertebral movement for the spinal interbody fusion. The rectangularcage with a vertical or oblique slot is inserted into the intervertebralspace from the lateral or anterior side of the spinal column and thenthe plate is inserted through the slot of the cage and hammered into andburied inside two adjacent vertebral bodies, to achievethree-dimensional intervertebral fixation.

The cited art does not disclose a fusion device that accommodatesanti-migration fixation elements adjacent to the device, wherein theanti-migration fixation elements are then secured to the fusion devicewith another component.

The prior art does not disclose a zero-profile cage with anti migrationelements secured into bone approximately adjacent to a surface of thecage within disc space, wherein the anti-migration fixation elementshave the ability to provide compression onto the graft area uponaddition of another component to the construct.

WO2009-064644 (Synthes) discloses a low profile intervertebral implantfor implantation in an intervertebral disc space in-between adjacentvertebral bodies. The intervertebral implant includes a plate preferablycoupled to a spacer. The plate is preferably formed from a firstmaterial and the spacer is preferably formed from a second material, thefirst material being different from the second material. The plate ispreferably sized and configured so that the plate does not extend beyondthe perimeter of the spacer. In this manner, the plate preferably doesnot increase the height profile of the spacer and the plate may beimplanted within the intervertebral disc space in conjunction with thespacer.

SUMMARY OF THE INVENTION

In a first embodiment of the present invention, there is provided anangled fixation device, such as an angled screw. This angled fixationdevice may be used by the surgeon to secure a spacer to a spinal discspace. The proximal end portion of the angled fixation device is drivenperpendicular to the anterior wall of the spacer, and so is parallel tothe vertebral endplates and in-line with the inserter. The distal endportion of the angled fixation device is oriented at about a 45 degreeangle (plus or minus 30 degrees) to the vertebral endplate it enters. Ininserting the angled fixation device, the surgeon advances the drivemechanism perpendicular to the anterior wall of the spacer (and parallelto the endplates) to force the angled fixation device to take an angledtrajectory into the adjacent vertebral body.

The in-line insertion of the angled fixation device allows for a smallerincision and access site for the spacer and angled fixation device, andalso allows the surgeon to avoid having to insert the fixation devicewith the inserter disposed at a sharp angle. This essentially in-lineapproach can be especially advantageous for the cervical spine, as itallows the surgeon to avoid the patient's chin or sternum.

Therefore, in accordance with the present invention, there is providedintervertebral device comprising:

-   -   a) an intervertebral spacer having an anterior wall, a posterior        wall, and first and second side walls connecting the anterior        and posterior walls, the anterior wall having an anterior        surface, an upper surface and a lower surface, a first        throughhole extending upwards from the anterior surface and a        second throughhole extending downwards from the anterior        surface,        -   b) a first screw received in the first throughhole, the            first screw having a distal tip, an intermediate shaft            having a threadform thereon, and a proximal head,    -   wherein the shaft of the first screw is angled.

Therefore, in accordance with the present invention, there is provided amedical implant comprising:

-   -   a) a wall having an upper surface and a lower surface, and a        front surface, and a first hole extending into the wall from the        front surface,    -   b) a first screw received in the first hole and having a distal        tip, an intermediate shaft having a first thread, and a proximal        head,        wherein a portion of the shaft is disposed at an angle to the        first hole.

Therefore, in accordance with the present invention, there is providedan intervertebral device comprising:

-   -   a) an intervertebral spacer having an anterior wall, a posterior        wall, and first and second side walls connecting the anterior        and posterior walls, the anterior wall having an anterior        surface, an upper surface and a lower surface, a first        throughhole extending upwards from the anterior surface and a        second throughhole extending downwards from the anterior        surface,        -   b) a first nail received in the first throughhole, the first            nail having a distal tip, an intermediate shaft having a            plurality of barbs thereon, and a proximal head,    -   wherein the shaft of the first nail is angled.

DESCRIPTION OF THE FIGURES

FIGS. 1A and 1B disclose jointed screws of the present invention.

FIGS. 1C and 1D disclose cages for use with the jointed screw of thepresent invention.

FIGS. 1E and 1F disclose the jointed screw and cage implanted in a disc.

FIG. 2A discloses one embodiment of a stand alone cage of the presentinvention.

FIGS. 2B-3C disclose stand alone cage of the present invention withscrews.

FIGS. 4A-4U disclose various embodiments of stand alone cages comprisingdissimilar materials.

FIG. 4V discloses a plate of a stand alone cage.

FIGS. 5A-5W disclose various embodiments and component of a stand alonecage having an anti-backout feature.

FIGS. 6A-6I discloses various embodiments and components of a standalone cage having fins.

FIGS. 6J-6U disclose a method of implanting a stand alone cage of thepresent invention.

FIGS. 6V-6X discloses various components of a stand alone cage havingfins.

FIG. 7A-7B disclose barbed bone anchors of the present invention.

FIG. 8 discloses a fusion device wherein the posterior wall and thefirst and second side walls form an integral body.

FIG. 9 discloses an exploded view of the intervertebral fusion device ofFIG. 8 wherein the integral body and the anterior wall are connected bya pair of pins.

FIG. 10 discloses pins received within the interlocking features of theanterior wall.

FIG. 11 discloses an embodiment of the present invention wherein theintegral body comprises allogenic bone.

FIGS. 12A-C disclose an inserter tip of the present invention.

FIGS. 13A-D disclose front views of an embodiment of the presentinvention including a retaining plate, and components thereof

FIGS. 14A-15B disclose top views of a retaining plate embodiment of thepresent invention including a living spring, and components thereof

FIG. 16 discloses a front view of a retaining plate embodiment of thepresent invention including a living spring and a chamfered insertionfeature.

FIG. 17 discloses an inserter instrument engaged with a retaining plateof the present invention.

FIG. 18 discloses a chamfered retaining plate and cage (partial) of thepresent invention.

FIGS. 19A-C, 20 and 21 disclose different views of a fixation cage witha secondary washer for insertion into a disc space.

FIG. 22 depicts a washer configured to be seated in a recess in ananterior portion of a fixation cage.

DETAILED DESCRIPTION OF THE INVENTION

For the purposes of the present invention, a “cage” is the spacer of thepresent invention without the anterior wall. That is, the cage consistsessentially of the posterior wall and the first and second side walls.The anterior wall may also be referred to as a “faceplate”.

Now referring to FIG. 1A, in some embodiments, there is provided a firstscrew 3 having a distal tip 2 an intermediate shaft 4 having athreadform 6 thereon, and a proximal head 8. The angled shaft portion 1of the first screw 3 is made of a flexible material. Now referring toFIG. 1B, in other embodiments, there is provided a second screw 5 havinga distal tip 2 an intermediate shaft 4 having a threadform 6 thereon,and a proximal head 8. The angled shaft portion 7 includes a joint, suchas a universal joint or a ball-and-socket joint.

Now referring to FIGS. 1A-1F, there is provided an intervertebral devicecomprising:

-   -   a) an intervertebral spacer 9 having an anterior wall 11, a        posterior wall 13, and first and second side walls 14 connecting        the anterior and posterior walls, the anterior wall having an        anterior surface 16, an upper surface 18 and a lower surface 20,        a first throughhole 22 extending upwards from the anterior        surface and a second throughhole 24 extending downwards from the        anterior surface,    -   b) a first bone fastener (such as screw 15) received in the        first throughhole, the first screw having a distal tip 17, an        intermediate shaft 19 having a threadform 21 thereon, and a        proximal head 23,    -   wherein the shaft of the first screw is angled.

In some embodiments, the angled shaft is made of a flexible structure,while in others, the angled shaft includes a joint, such as a universaljoint or a ball-and-socket joint.

In some embodiments, the screw can be replaced by a nail having barbs.

In some embodiments, the spacer comprises a cage consisting essentiallyof the posterior wall and the first and second side walls, and theanterior wall is a separately manufactured faceplate that is mated tothe cage.

In some embodiments, the first throughhole extends upwards through theupper surface of the anterior wall, and the second throughhole extendsdownwards through the lower surface of the anterior wall.

In some embodiments, the first throughhole 22 has an anterior portion 26that extends substantially perpendicular to the anterior wall, and aposterior portion 28 that extends to the upper surface 18 of theanterior wall. In addition, posterior portion 28 can extend partially orfully into the graft window (not just the upper surface).

In some embodiments, wherein the anterior wall comprises a posteriorsurface 30, and the first throughhole extends upwards through theposterior surface of the anterior wall, and the second throughholeextends downwards through the posterior surface of the anterior wall.

In some embodiments, there is provided a second screw received in thesecond throughhole, the second screw having a distal tip, anintermediate shaft having a threadform thereon, and a proximal head,wherein the shaft of the second screw is angled.

Thus, the device of the present invention can generally be considered tobe a medical implant comprising:

-   -   a) a wall having an upper surface and a lower surface, and a        front surface, and a first hole extending into the wall from the        front surface,    -   b) a first screw received in the first hole and having a distal        tip, an intermediate shaft having a first thread, and a proximal        head,        wherein a portion of the shaft is disposed at an angle to the        first hole.

In this general embodiment, the first hole preferably extends into thewall at an angle that is not perpendicular to the front surface, and theshaft of the first screw is angled. Preferably, the shaft of the firstscrew is flexible.

Thus, the present invention can also generally be considered to be amethod of fixing a medical implant having a wall having a front surfaceand a first hole extending into the wall from the front surface, themethod comprising the steps of:

-   -   a) implanting the implant in a patient, and    -   b) inserting a first screw having a shaft into the first hole,        wherein a portion of the shaft is disposed at an angle to the        first hole during insertion.

For the purposes of the present invention, the flexible structurecomprising the angled shaft can be either made of an intrinsicallyflexible material or an intrinsically stiff material having a geometrythat enables flexing or bending.

In inserting the angled fixation device, and now referring to FIG. 1E,the surgeon advances the drive mechanism 973 of the inserter 371perpendicular to the anterior wall of the spacer (and parallel to theendplates) to force the angled fixation device to take an angledtrajectory into the adjacent vertebral body.

Second Aspect of the Invention

In accordance with the present invention, there is provided azero-profile or low-profile implant that can be used in a fusionprocedure and sit completely inside the disc space. The implant includesfeatures incorporated into one or more surfaces of the implant thatcontrol the amount of endplate subsidence into the implant. Thesefeatures can be positioned around the periphery of the implant tocapture targeted bone.

In general, a “controlled subsidence feature” on an implant providesincreasing resistance against endplate subsidence as the subsidenceprogresses into the implant. The increase in resistance is generallyaccomplished by increasing the contact area between the implant and theendplates, thereby lowering the maximum stress experienced by theendplates. Typically, any surface having an acutely angled projectionwill function so as to control subsidence. Such a projection will havegreater and greater contact with the endplate as the endplate subsidesinto the implant. Typically, controlled subsidence features includepyramids, cones and wedges. In some embodiments, the controlledsubsidence feature is a pointed projection extending outward from anupper or lower surface of the implant. Such a feature will also helpprevent cage migration as well as increase the implant's rotationalstability.

In some embodiments, the implant comprises two separate components: athree-walled cage plus an anterior faceplate having a desirablemechanical rigidity that can house a cam, bushing, and/or a thread formto allow anchors to pass therethrough, if desired.

Also disclosed is a method of securing the cage of the present inventionto one or more levels of the spine with optional fixation devices, suchas bone anchors such as screws. The optional fixation device preferablypasses through at least a portion of the anterior wall of the cage. Inthese embodiments, the fixation devices enter the superior and inferiorvertebral bodies somewhere in and along the anterior wall from within orpartially within the disc space. The hybrid plate/cage assembly of thepresent invention having optional fixation essentially creates a nearzero-profile assembly.

In some embodiments, the anterior wall is a separately-manufacturedfaceplate having anti-migration features. This faceplate can attach to aseparate cage component made from such diverse materials as ceramics,hydroxyapatite, tricalcium phosphate, allograft, CFRP, PEEK andEndolign. These components can couple to each other from numerous planes(i.e., from the front-to-back, from the top-to-bottom, and from theside-to-side) so as to form a desirable net shape assembly that conformsto the patient anatomy based on the chosen surgical approach.

In some embodiments, there is provided a multi-piece intervertebralfusion device assembly having anti-migration/anti-expulsion features onboth cage and faceplate components.

In some embodiments, there is provided an implant having a thin anteriorwall containing features designed to control subsidence into bone.Preferably, these features are present on both the upper and lower facesof the anterior wall and are distributed evenly across the anteriorwall. More preferably they are symmetrically distributed.

In some embodiments, the anti-migration features of the faceplate are inthe form of a pyramid, tooth, spike, diamond, keel or ridge. They aredistributed anatomically across the front face to assist in load sharingwith the graft spacer and to aid in ensuring final placement prior tofusion.

Now referring to FIGS. 2A-2C, there is provided an intervertebral device201 for insertion into a disc space defined by opposing vertebralendplates, comprising

-   i) an intervertebral spacer 203 comprising:    -   a) an anterior wall 205 having an upper surface 207 and a lower        surface, an anterior surface 209, and a first throughhole 211        extending upwards from the anterior surface and a second        throughhole 213 extending downwards from the anterior surface,    -   b) a posterior wall 215 having an upper surface 217 and a lower        surface, and    -   c) first and second side walls 219 connecting the anterior and        posterior walls, each side wall having an upper surface 221 and        a lower surface,-   ii) a first bone anchor 223 received in the first through hole,-   iii) a second bone anchor 225 received in the second through hole,-   wherein the upper and lower surfaces of the anterior wall contact    the opposing vertebral endplates,-   wherein at least one of the upper and lower surfaces of the anterior    wall comprises a controlled subsidence feature 227,-   wherein the anterior wall is characterized by a material having an    intrinsic strength, the remainder of the spacer is characterized by    a material having an intrinsic strength, and the intrinsic strength    of the material of the anterior wall is greater than the intrinsic    strength of the material of the remainder of the spacer.

In some embodiments, each of the upper or lower surfaces of the anteriorwall comprises a controlled subsidence feature.

In some embodiments, the controlled subsidence feature acts to increasecontact area between the spacer and the endplates as subsidenceincreases.

In some embodiments, the controlled subsidence feature comprises anacutely angled projection 229 extending outwards from the upper or lowersurface of the anterior wall.

In some embodiments, the controlled subsidence feature is selected fromthe group consisting of a pyramid, a cone and a wedge.

In some embodiments, the anterior wall comprises attachment features forattaching to the side walls.

In some embodiments, at least one side wall comprises a controlledsubsidence feature.

Now referring to FIG. 2C, there is provided an intervertebral device forinsertion into a disc space defined by opposing vertebral endplates, thedevice having an anterior-most surface and comprising

-   i) an intervertebral cage 230 comprising:    -   a) a posterior wall having an upper surface and a lower surface,        and    -   b) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a faceplate 231 attaching to each of the side walls and forming    the anterior-most surface of the device, the faceplate having an    upper surface and a lower surface, and an anterior surface,-   iii) a first bone anchor extending upwards and posteriorly from the    cage and-   iv) a second bone anchor extending downwards and posteriorly from    the cage,

wherein the upper and lower surfaces of the faceplate contact theopposing vertebral endplates,

wherein at least one of the upper and lower surfaces of the faceplatecomprises a controlled subsidence feature.

In some embodiments, there is provided an intervertebral device forinsertion into a disc space defined by opposing vertebral endplates,comprising

-   i) an intervertebral spacer comprising:    -   a) an anterior wall having an upper surface and a lower surface,        an anterior surface, and a first throughhole extending upwards        from the anterior surface and a second throughhole extending        downwards from the anterior surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first bone anchor received in the first through hole,-   iii) a second bone anchor received in the second through hole,-   wherein the upper and lower surfaces of the anterior wall contact    the opposing vertebral endplates,-   wherein the upper and lower surfaces of the anterior wall define an    anterior wall height, and-   wherein the upper and lower surfaces of the posterior wall define a    posterior wall height, and-   wherein the anterior wall height is greater than the posterior wall    height.

Preferably, at least one of the upper and lower surfaces of thefaceplate comprises a controlled subsidence feature.

Also in accordance with the present invention, there is provided amethod of inserting an intervertebral device into a disc space, whereinthe device comprises,

-   i) an intervertebral spacer comprising:    -   a) an anterior wall having an upper surface and a lower surface,        an anterior surface, and a first throughhole extending upwards        from the anterior surface and a second throughhole extending        downwards from the anterior surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first bone anchor received in the first through hole,-   iii) a second bone anchor received in the second through hole,-   wherein at least one of the upper and lower surfaces of the anterior    wall comprises a controlled subsidence feature,-   wherein the anterior wall is manufactured as a separate component    from a remainder of the spacer,-   the method comprising the steps of:    -   a) creating the disc space between opposing vertebral endplates,        and    -   b) inserting the device into the disc space so that the upper        and lower surfaces of the anterior wall contact the opposing        vertebral endplates.

Preferably, the anterior wall is characterized by a material having anintrinsic strength, the remainder of the spacer is characterized by amaterial having an intrinsic strength, and the intrinsic strength of thematerial of the anterior wall is greater than the intrinsic strength ofthe material of the remainder of the spacer.

Third Aspect of the Invention

In some embodiments, the screw associated with the stand aloneintervertebral fusion devices of the present invention has an enhancedfixation feature. For the purposes of the present invention, a screwhaving an enhanced fixation feature is selected from the groupconsisting of:

-   -   a) a screw coated with bone ingrowth substance such as        hydroxyapatite or titanium calcium phosphate. Such a screw would        be desirable for use in an aged patient whose osteogenic profile        may not be able to provide appropriate bone in-growth;    -   b) a fenestrated screw for use with either cement or biologic        injections or bone ingrowth material. Such a screw may be useful        in improving the pull-out strength of the screw in osteoporotic        bone;    -   c) an expanding screw, which may be useful in preventing device        migration;    -   d) a cannulated screw, which may be useful in percutaneous or        other minimally invasive procedures using a guidewire;    -   e) a resorbable screw that could be gradually eliminated from        the patient as fusion occurred. Such a screw could be made from        a resorbable material such as PLA, PGA, PLGA, HA-filedd polymer,        TCP-filled polymer, or BIOCRYL RAPIDE™.    -   f) a screw coated with an anti-bacterial agent, which could be        particularly useful in treating trauma cases that pose infection        risks; and    -   g) a nail having fins extending therefrom (such as a shoulder        anchor such as the MITEK™ shoulder anchor.

Now generally referring to FIGS. 3a-3c , there is provided anintervertebral device for insertion into a disc space defined byopposing vertebral endplates, comprising

-   i) an intervertebral spacer 310 comprising:    -   a) having an anterior wall 311 having an upper surface 312 and a        lower surface 313, an anterior surface 314, and a first hole 315        extending from the anterior surface to the upper surface and a        second hole 316 extending from the anterior surface to the lower        surface,    -   b) a posterior wall 317 having an upper surface 318 and a lower        surface 319, and    -   c) first and second side walls 320 connecting the anterior and        posterior walls, each side wall having an upper surface 321 and        a lower surface 322,-   ii) a first screw 325 received in the first hole and having a distal    tip 326, an intermediate shaft 327 having a first thread 328, and a    proximal head 329, and-   iii) a second screw 335 received in the first hole and having a    distal tip, an intermediate shaft 337 having a first thread, and a    proximal head 339.

Fourth Aspect of the Invention

In accordance with the present invention, there is provided anintervertebral implant comprising a spacer made of two or morecomponents made of dissimilar materials coupled together to takeadvantage of the material properties of each selected material. Thesecomponents can be coupled via various disclosed geometries.

Now referring to FIG. 4A, there is provided, in one embodiment, a devicecomprising a) a cage 411 comprising bone (preferably at least 50 v/obone) and b) a faceplate 413 comprising a metallic or polymericmaterial, wherein the faceplate attaches to the bone. In one suchembodiment, there is provided an anterior wall consisting essentially ofa metallic material, with the remainder of the spacer consistingessentially of bone. One advantage of this design is that it providesmore graft-endplate contact than conventional designs that delivergraft. This contact advantage is particularly clear when the device ofthe present invention is compared to a conventional synthetic spacerhaving a graft chamber. Because of the enhanced strength of the anteriorwall of this design, it may be possible to pass bone anchors through anaperture in the metallic anterior wall portion of the device.

Therefore, in accordance with the present invention, there is providedan intervertebral device for insertion into a disc space defined byopposing vertebral endplates, comprising

-   i) an intervertebral spacer comprising:    -   a) having an anterior wall having an upper surface and a lower        surface, an anterior surface, and a first hole extending from        the anterior surface to the upper surface and a second hole        extending from the anterior surface to the lower surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first bone anchor received in the first hole, the first bone    anchor having a distal tip, an intermediate shaft, and a proximal    head,-   iii) a second bone anchor received in the second hole, the second    bone anchor having a distal tip, an intermediate shaft, and a    proximal head,

wherein the anterior wall is made of a first material and a remainder ofthe spacer is made of a second material, and

wherein the anterior wall is fixed into the remainder of the spacer sothat it does not float.

In some embodiments, the bone cage and metallic faceplate possessmatching engagement features, such as dovetail features 415.

In some embodiments, and now referring to FIG. 4B, the metal faceplatehas arms 417 that wrap around the bone cage and meet to form a posteriorwall 419.

In some embodiments, and now referring to FIG. 4C, the metal faceplate420 has lateral prongs 421 fit into mating recesses 423 machined intothe anterior face 425 of the bone cage.

In alternative embodiments, the material of the anterior wall is lessstiff than the material of the remainder of the spacer (i.e., the cage).This condition allows more load to be taken by bone graft containedwithin a hollow of the cage. This design could also provide apredetermined amount of micromotion and/or springback, which may bedesirable.

Therefore, in accordance with the present invention, there is providedan intervertebral device for insertion into a disc space defined byopposing vertebral endplates, comprising

-   i) an intervertebral spacer comprising:    -   a) an anterior wall having an upper surface and a lower surface,        an anterior surface, and a first through hole extending upwards        from the anterior surface and a second through hole extending        downwards from the anterior surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first bone anchor received in the first through hole,-   iii) a second bone anchor received in the second though hole,-   wherein the anterior wall is made of a first material and a    remainder of the spacer is made of a second material,-   wherein the material of the anterior wall has a stiffness, the    material of the remainder of the spacer has a stiffness, and the    stiffness of the anterior wall material is less than the stiffness    of the material of the remainder of the spacer.

In general, the dissimilar nature of the materials could causeundesirable micromotion if they were placed next to each other in afloating arrangement. Therefore, it is desirable to fix the twocomponents together to form a non-displaceable, non-floating connection.

In some embodiments, the faceplate is front loaded onto the cage.

Now referring to FIG. 4D, in some embodiments, the fixed connection ofthe present invention is accomplished by providing aligned holes in thecage and faceplate and inserting at least one cross pin 401therethrough.

In one embodiment thereof, and now referring to FIG. 4E, the faceplate422 has wings 424 extending posterior, and the wings have holes 425.When this faceplate is attached to the front of the cage, the holes ofthe faceplate aligned with holes 427 provided on the sidewalls 429 ofthe cage.

In one embodiment, and now referring to FIG. 4F, the faceplate 430 has apair of prongs 431 fitting into a central recess 433 machined into theanterior face 435 of the cage.

In one embodiment, and now referring to FIG. 4G, the faceplate 437 andthe anterior face 439 of the cage are mated through threaded features441.

In one embodiments, and now referring to FIG. 4H, the faceplate 443 hasa U-shape and is wraps around the anterior wall 445 of the cage. Thisfaceplate is preferably press fit onto the anterior wall of the cage.The arms 442 of the faceplate contact the inferior 444 and superior 446faces of the cage.

In preferred embodiments thereof, and now referring to FIG. 4I, theU-shaped faceplate has prongs 447 thereon that provide additionalsecurement to the bone cage.

In preferred embodiments thereof, and now referring to FIG. 4J, theU-shaped faceplate has disperse lances 449 therein that provideadditional securement to the bone cage.

In some preferred embodiments thereof, and now referring to FIG. 4K, theU-shaped faceplate 451 is received into a recess in the anterior wall453 of the cage so that the posterior face 455 of the faceplate is flushwith the anterior surface 457 of the cage.

In one embodiments, and now referring to FIG. 4L, the faceplate 463 hasa U-shape and is wraps around the anterior wall 465 of the cage. Thisfaceplate is preferably press fit onto the anterior wall of the cage.The arms 462 of the faceplate contact the side walls 464 of the cage.

In one embodiments, and now referring to FIG. 4M, the faceplate 467 hasa pin 469 extending posteriorly therefrom, and this pin extending into amating recess 471 provided on the anterior face 473 of the cage.

In some embodiments, the faceplate is side loaded onto the cage.

In some embodiments thereof, and now referring to FIG. 4N, the faceplate475 has dovetails 477 extending posteriorly therefrom, while theanterior face 479 of the bone cage 481 has dovetail recesses 483 formedtherein. The dovetails of the faceplate are sideloaded into the dovetailrecesses.

In some embodiments thereof, and now referring to FIG. 4O, the faceplate485 has tabs 487 extending posteriorly therefrom, within holes 489extending tabs. This faceplate is sideloaded into a cage having a recess491 that extends substantially laterally across the anterior face 493 ofthe cage and partially down a sidewall 495 as well. The upper surface496 of the cage has a pair of holes 497 bored therein so that the holesof the cage align with the holes of the faceplate. Into these alignedholes is inserted an insertion pin 498.

In some embodiments, the faceplate is top loaded onto the cage.

In some embodiments thereof, and now referring to FIG. 4P, the faceplate301 has tabs 303 extending laterally therefrom, and insertion pins 305extending from the tabs in the superior direction. Similarly, the cage307 has tabs 309 extending laterally therefrom, and insertion holesextending through the tabs in the superior direction. The cage andfaceplate are mated in a press fit fashion so that the insertion pin ofthe faceplate extends through the insertion hole of the cage.

In some embodiments thereof, and now referring to FIG. 4Q, the faceplate311 has tabs 313 extending laterally therefrom. Similarly, the cage 317has tabs 319 extending laterally therefrom. These tabs are formed in ajigsaw puzzle manner so that the cage and faceplate can be mated in apress fit fashion so that the tab of the faceplate mates with the tab ofthe cage.

In some embodiments thereof, and now referring to FIG. 4R, the faceplate321 has a dovetail 323 extending posteriorly therefrom. Similarly, theanterior wall 325 of the cage 327 has a dovetail recess thereinextending from the upper surface 329 to the lower surface of the cage.The faceplate is top or bottom loaded into the cage so that the dovetailand corresponding recess mate.

In some embodiments thereof, and now referring to FIG. 4S, the faceplate331 is essentially a band that wraps around the cage. Provided on theposterior portion of the faceplate is a plurality of crush ribs 333 thatenhance the friction fit with the cage (not shown).

In some embodiments thereof, and now referring to FIG. 4T, the faceplate341 has outer arms 335 that form an outside dovetail with the cage 343.

In some embodiments thereof, and now referring to FIG. 4U, the faceplate351 has a-plurality of dovetails 353 extending posteriorly therefrom.Similarly, the anterior wall 355 of the cage 357 has a plurality ofdovetail recesses therein extending from the upper surface 359 to thelower surface of the cage. The faceplate is top or bottom loaded intothe cage so that the dovetails and corresponding recesses mate.

Now referring to FIG. 4V in some embodiments, the fixed connection ofthe present invention is accomplished by providing insertion pins 403 onthe posterior wall 405 of the faceplate 407, along with aligned recesseson the anterior portion of the cage. The insertion pins are then cooledso that they contract. The insertion pins are then inserted into thealigned recesses in the anterior portion of the cage. Once the insertionpins warm, they expand and provide a secure friction fit.

In some embodiments, assembly of the two components could take place inthe operating room due to the modularity of the design, thus allowingfor intra-operative decision making.

As used herein, the term “bone graft” may include both synthetic bone(such as synthetic hydroxyapatite) and natural bone (such as allograft).

Fifth Aspect of the Invention

There is sometimes a need to re-operate on or revise a patient having anintervertebral spacer that has been secured in place by screws becausethe screw-spacer interface does not function as intended and so poses arisk of screw backout. Screw backout is a well known safety issue.Accordingly, the surgeon must often engage in extra surgical steps, suchas passing another instrument through to the site and turning a cam orcover plate.

In accordance with the present invention, there is provided a standalone intervertebral fusion device that provides enhanced securement ofthe screw to the spacer, and so prevents backout. The designincorporates securement features into the basic device design as part ofthe spacer's screw hole and as part of the basic screw, and so does notadd additional components to the device that could increase profile andcomplexity. Now referring to FIGS. 5A-5B, the screw hole 500 includes amachined-in ring 501 that is at least partially (and preferably fully)circumferential and is fully contained within the screw hole. Nowreferring to FIGS. 5C-5E, as for the screw 502, the proximal end portion503 of its thread 504 includes a proximal sidewall 535 that runsparallel to the ring. In use, the thread passes over the ring to allowpassage of the screw into the hole. Once the screw is threaded intoposition so that the entire threadform has passed over the ring, thedistal portion of the screw head proximally abuts the ring, therebypreventing further advance. In addition, if the screw were to beginbackout, the last turn of the screw thread (i.e., the proximal endportion of the thread having the parallel sidewall) would soon abutagainst the ring, thereby preventing backout.

In some embodiments, the ring is sized to provide engagement with theroot and/or side wells of the crest of the thread of the screw shank toallow for screw advancement. This mimics a helical threadform machinedinto the aperture, but need not be a helix.

Due to these design features, the interface between the screw and thespacer in these embodiments should have superior push out strength, easeof use and backout resistance (as compared to previous designs such as abushing). This is because it is an integral machined-in lip with fewerfailure modes. In addition, this design of the present invention willallow the surgeon to secure the screw in a single step-by simplyadvancing and bottoming out the screw in the spacer, thereby eliminatingextra steps for the surgeon to perform. In addition, the design isrobust in that it can accommodate rigid or variable screws and allow forcontrolled screw toggle depending on the surgeon's desire.

Therefore, in accordance with the present invention, there is providedan intervertebral device for insertion into a disc space defined byopposing vertebral endplates, comprising

-   i) an intervertebral spacer comprising:    -   a) having an anterior wall having an upper surface and a lower        surface, an anterior surface, and a first hole extending from        the anterior surface to the upper surface and a second hole        extending from the anterior surface to the lower surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first screw received in the first hole and having a distal    tip, an intermediate shaft having a first thread, and a proximal    head,-   iii) a second screw received in the second hole and having a distal    tip, an intermediate shaft having a second thread, and a proximal    head,

wherein the anterior wall has a first hole surface having a first ringextending therefrom,

wherein the first thread has a proximal end portion having a proximalside wall that runs substantially parallel to the ring.

In some embodiments, the proximal end portion of the thread can have acontour selected from the group consisting of a straight cut 503 (as inFIG. 5C), a relief cut, or a reverse cut 505 (as in FIG. 5D).

In some embodiments, the machined-in ring can have a contour selectedfrom the group consisting of a straight cut 507 (as in FIG. 5F), arelief cut 509 (as in FIG. 5G) or a reverse cut 508 (as in FIG. 5H).

In some embodiments, the proximal end portion of the thread having theparallel sidewall includes substantially all of the run-out portion ofthe thread.

Therefore, and now referring to FIGS. 5I-5K, there is provided anintervertebral device for insertion into a disc space defined byopposing vertebral endplates, comprising

-   i) an intervertebral spacer 510 comprising:    -   a) having an anterior wall 511 having an upper surface 512 and a        lower surface 513, an anterior surface 514, and a first hole 515        extending from the anterior surface to the upper surface and a        second hole 516 extending from the anterior surface to the lower        surface,    -   b) a posterior wall 517 having an upper surface 518 and a lower        surface 519, and    -   c) first and second side walls 520 connecting the anterior and        posterior walls, each side wall having an upper surface 521 and        a lower surface 522,-   ii) a first screw 525 received in the first hole and having a distal    tip 526, an intermediate shaft 527 having a first thread 528, and a    proximal head 529,-   iii) a second screw received in the second hole and having a distal    tip, an intermediate shaft having a second thread, and a proximal    head,

wherein the anterior wall has a first hole surface 530 having a firstring 531 extending therefrom,

wherein the first thread has a proximal end portion having a proximalside wall 535 that runs substantially parallel to the ring.

In some embodiments, the first ring abuts the proximal side wall toprevent backout. Preferably, the ring is sized to allow for passage ofthe first thread to allow for screw advancement. In some embodiments,the first ring is fully circumferential, while in others it is partiallycircumferential. In some embodiments, the first ring is an integralportion of the anterior wall. In some embodiments, the first ring ismanufactured separately from the anterior wall.

Thus, the present invention generally relates to a medical implantcomprising:

-   -   a) a wall having an upper surface and a lower surface, and a        front surface, and a first hole extending into the wall from the        front surface,    -   b) a first screw received in the first hole and having a distal        tip, an intermediate shaft having a first thread, and a proximal        head,

wherein the wall has a first hole surface having a first ring extendingtherefrom,

wherein the first thread has a proximal end portion having a proximalsidewall that runs substantially parallel to the ring.

Likewise, the method of using the present invention generally relates toa method of fixing an implant comprising a wall having a front surfaceand a first hole extending into the wall from the front surface, whereinthe wall has a first hole surface having a first ring extendingtherefrom, the method comprising the steps of:

-   -   a) placing the implant against a bone, and    -   b) selecting a first screw having a distal tip, an intermediate        shaft having a first thread, and a proximal head, wherein the        first thread has a proximal end portion having a proximal        sidewall that runs substantially parallel to the ring,    -   c) inserting a first screw through the first hole and into the        bone.

In some embodiments, the first screw is inserted into the bone so thatthe proximal end portion of the first thread is advanced past the ring.In some embodiments, the first screw is inserted into the bone so thatthe ring is disposed between the proximal end portion of the firstthread and the proximal head. In some embodiments, the length of thisneck portion can be varied depending on the level of desiredcompression.

Now referring to the anti-backout embodiment of FIGS. 5L-5N, there is ahelical ring 551 to prevent the screw 553 from backing out afterinsertion. The pitch and shape of the helical ring matches that of thescrew so that the screw can be easily inserted. Once the screw has beenfully inserted the bottom of the screw head 555 will be in contact withthe top 557 of the helical ring. At this point all of the threads 559 onthe screw will have fully passed through the helix on the faceplate andthe helix will reside between the bottom of the screw head and the endof the last thread on the screw. In order to remove the screw, thethreads would have to be re-engaged with the helix. An axial load wouldnot allow the screw to backout once the screw is properly inserted.

Now referring to FIGS. 50-5S, this anti-backout embodiment comprises a)multiple spring tabs 561 that are formed from recesses 563 cut into thedistal surface 565 of the head of the screw and b) a mating groove inthe faceplate. When the screw is inserted into the bone, the bottom ofthe screw head pushes against a continuous ring so that it cannot gothrough the face plate. At the same time, protrusions 567 on the screwhead spring tabs pop into the mating groove on the faceplate to preventthe screw from being able to back out of the faceplate.

Now referring to FIGS. 5T-5W, in this embodiment anti-backout isachieved through the use of a balseal 569. A groove 571 is cut into thefaceplate in which a circular spring 573 is placed. Another groove 575is cut into the head 577 of the screw 579. When the screw is inserted,the bottom of the head will become fully seated against a ring in thefaceplate. At this time, the geometry of the head of the screw will haveflattened out the spring and once fully seated the spring will recoverto its normal position and be housed in the groove on the head of thescrew thereby preventing the screw from backing out. The geometry on thehead of the screw can be designed so that a minimal amount of force(such as one pound) is required to lock the screw into the spring but agreater force (such as 25 pounds) is required to removed the screw fromthe balseal.

Sixth Aspect of the Present Invention

After performing an anterior approach discectomy and insertion of aspacer/cage, some spine surgeons prefer not to insert a plate on theanterior surface of a patient with fixation through the anterior face ofthe cephalaud and caudal vertebral bodies. Often times, the plate can beconsidered to be too proud and its profile can sometimes cause patientdiscomfort and cause dysphasia.

Disclosed is a method of securing an intervertebral fusion cage to anintervertebral disc space with fixation elements, and numerous implantembodiments therefor. After the cage is placed and positioned per thesurgeon preference, the fixation elements (such as fins, pins, blades,plates, keels, and hooks) are inserted up against a proximal face of thecage. The fixation elements are inserted into the cage in an orientationsubstantially perpendicular to the proximal face of the cage, andsubstantially in-line with the inserter. The fixation elements are thendeflected outward from the cage during insertion by a sloped feature onthe anterior surface of the cage. Preferably, this sloped feature is atapered section defining an upward sloping surface and a downwardsloping surface. Ideally, the deflected fixation elements penetrate theadjacent vertebral bodies and are secured in place with a compressioncap.

Once placed in their desired locations, the fixation elements mayfurther provide compression onto the cage. The fixation elements arepreferably made of materials and possess shapes designed to accomplishthis function. Materials that preferably allow the fixation elements toaccomplish this compression function include metals such as stainlesssteel and titanium alloy, polymers, autograft, allograft, ceramics, andresorbable materials such as HA and TCP. Geometries that preferablyallow the fixation elements to accomplish this compression functioninclude those provided in FIGS. 6A-6W.

The fixation cage of the present invention allows the surgeon to createa smaller incision and access site for the cage and fixation elementsbecause direct access that is parallel to the disc space is provided.The in-line insertion of the fixation elements also allows the surgeonto avoid having to insert the fixation elements on a high angle throughsometimes challenging approaches.

Now referring to FIG. 6A-6C, there is provided, an intervertebralimplant 600 comprising:

-   -   a) an intervertebral spacer 601 having an anterior wall 603, a        posterior wall 605, and first and second side walls 607        connecting the anterior and posterior walls, the anterior wall        having an anterior surface 609, an upper surface 611 and a lower        surface 613, wherein the anterior surface has a tapered section        615 defining an upward sloping surface 617 and a downward        sloping surface 619,    -   b) a first fin 621 having a proximal section 623, an        intermediate section 625 and a distal section 627,    -   c) a compression cap 629 having a first portion 631 and a second        portion 633, wherein the first fin contacts the upward sloping        section of the tapered section of the anterior face,

wherein the distal section of the first fin extends above the uppersurface of the anterior wall, and

wherein the proximal section of the first fin contacts the first portionof the compression cap.

In some embodiments, the anterior wall further comprises a threaded hole635 located between the upward and downward sloping surfaces thereof,wherein the compression cap comprises a distal thread 637, and whereinthe threaded hole threadably receives the thread of the compression cap.This threaded connection provides a reliable means of securing the finsto the cage.

In some embodiments, there is provided a second fin 639 having aproximal section 641, an intermediate section 643 and a distal section645, wherein the second fin contacts the downward sloping section of thetapered section of the anterior face, wherein the distal section of thesecond fin extends below the lower surface of the anterior wall, andwherein the proximal section of the second fin contacts the secondportion of the compression cap. The second fin provides for bilateralfixation of the cage between the opposing vertebral bodies.

In some embodiments, the spacer further comprises a hollow portion 647between the anterior and posterior walls, wherein bone graft iscontained within the hollow, and wherein the fins impart compressiononto the bone graft. Thus, the fins provide an additional benefit ofbone graft compression to the device.

In some embodiments, the first fin comprises a concave surface 649 andan opposing convex surface 651. These surfaces provide the fin with anupward or downward curve that allows the fin to enter the opposingvertebral bodies in an orientation more perpendicular to the endplates.

In some embodiments, the convex surface of the first fin contacts theupward sloping surface of the tapered portion of the anterior surface ofthe anterior wall. This allows the upward sloping surface to determinethe angle of the fin as it extends into the vertebral body.

Now referring to FIG. 6D, in some embodiments, wherein at least one ofthe concave and convex surfaces of the first fin has a tooth 653extending therefrom. These teeth provide additional fixation characterto the fin. Preferably, at least one of the concave and convex surfacesof the first fin has a plurality of teeth extending therefrom.

Now referring to FIG. 6G, in some embodiments, at least one of theconcave and convex surfaces of the first fin has a groove 655 therein.This groove provides additional fixation character to the fin, or may bedesigned to allow for intentional bending/flexing to occur.

Now referring to FIG. 6D, in some embodiments, the first fin furthercomprises at least one side surface 657 extending between the concaveand convex surfaces, wherein the at least one side surface comprises atooth 659 thereon. These teeth provide additional fixation character tothe fin.

Now referring to FIG. 6E, in some embodiments, the distal section of thefirst fin comprises at least two tynes 660 forming a fork. The forkprovides two points of fixation and may provide a benefit when existinghardware from a previous surgery is in the space.

Now referring to FIG. 6F, in some embodiments, the proximal portion ofthe first fin has wings 661 extending laterally therefrom. The wingsprovide a stop and a pivot point. In some embodiments, thereof, thewings are flexible so as to provide rentention into the tapered anteriorwall surfaces.

Now referring to FIG. 6H, in some embodiments, the distal portion of thefirst fin is tapered 664. The taper provides ease of insertion into thebone segment. In some embodiments, the embodiment of FIG. 6H can have aplurality of throughholes running transverse to the fin, as shown inFIG. 6X. In this embodiment there are a series of geometricallypatterned holes 681 that pass through the fixation blade. These throughholes allow spaces for bone to grow through the blades and provide amore solid fixation and a more complete fusion. These blades or at leastthe holes could have an osteo-conductive coating to help initiate thisbone growth.

Now referring to FIG. 6I, in some embodiments, the proximal portion ofthe first fin has a longitudinal groove 666 therein to provideflexibility and/or retention.

In some embodiments, the proximal section of the first fin contacts theupward sloping section of the tapered section of the anterior face. Insome embodiments, the intermediate section of the first fin contacts theupward sloping section of the tapered section of the anterior face.

In some embodiments, the first fin extends above the upper surface ofthe anterior wall at an angle defined by the upward sloping section ofthe anterior wall. This allows the angle at which the fin extends intothe vertebral body to be predetermined by the implant.

In some embodiments, at least of the anterior wall, posterior wall, andfirst and second side walls of the intervertebral spacer furthercomprise an upper surface 663 and a lower surface 665 that are toothed667. These teeth provide additional fixation of the cage to thevertebral bodies. In some embodiments, each of the anterior wall,posterior wall, and first and second side walls of the intervertebralspacer further comprise upper and lower surfaces that are toothed.

FIGS. 6V and 6W disclose are alternate embodiments of a compression capfor the blade version. Both would have a fastener (i.e, a screw) thatwould pass through it and would attach to the opening on the anteriorface of the cage. FIG. 6V discloses cap 668 and FIG. 6W discloses cap670.

The insertion of the cage of the present invention may follow thefollowing procedure. Now referring to FIG. 6J, there is provided thespacer 601 of the present invention adjacent insertion device 670. Nowreferring to FIG. 6K, the spacer is attached to the insertion device toform assembly 671. Now referring to FIGS. 6L and 6M, the assembly isinserted into intervertebral disc space DS. Now referring to FIGS. 6Nand 60, first fin 621 is inserted into a groove 673 of the insertiondevice. Now referring to FIG. 6P-6R, the fin is pressed into place withinserter rod 675. Now referring to FIG. 6S-6U, compression cap 677 isinserted into the assembly to lock the fin to the spacer.

Although the cages of the present invention are preferably suited foruse in the cervical spine, they may also be used in the lumbar andthoracic spine as well.

Although the cages of the present invention are preferably suited foruse with a pair of bone screw, they may also be used with more than twofasteners. In some cases, the cage of the present invention is fastenedwith three bone screws provided in either a “one up/two down” or “twoup/one down” arrangement.

In some embodiments, and now referring to FIGS. 7A and 7B, the screw 701used with fusion cages of the present invention is modified wherein thethread of the screw is replaced with substantially circumferential ribs703 or barbs. In these embodiments, the device uses fins, barbs, or ribsas opposed to a threaded means for its fixation strength. This devicecan be tapped into a predrilled hole instead of threaded. This can leadto a faster and easier insertion of the fixation device without the riskof stripping out a threaded hole and losing fixation strength. Thenumber of barbs and the geometry of the barbs can be designed to get thebest fixation strength possible while requiring less force forinsertion.

In some embodiments, the spacer comprises bone extending continuouslybetween the anterior and posterior walls, and wherein the fins impartcompression to the bone.

Seventh Aspect of the Invention

Now referring to FIG. 8, there is provided an intervertebral fusiondevice of the present invention, comprising:

-   i) an intervertebral spacer 751 comprising:    -   a) an anterior wall 753 having an upper surface and a lower        surface, an anterior surface, and a first throughhole extending        upwards from the anterior surface and a second throughhole        extending downwards from the anterior surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first bone anchor 755 received in the first through hole,-   iii) a second bone anchor 757 received in the second through hole,

wherein the posterior wall and the first and second side walls form anintegral body 759.

In one embodiment, the two pieces of the spacer have interlockingsurfaces that are connected by transverse pins. FIG. 9 discloses anexploded view of the spacer of FIG. 8 wherein the integral body 759 andthe anterior wall 753 are connected by a pair of pins 761. The anteriorwall 753 has tongue features 754 having holes therein, while theanterior portion 756 of the integral body has groove features 758 havingholes 760 therein, wherein the holes align when the tongue and grooveinterlock and receive the pins.

In other embodiments, these components may be assembled with a one-waysnap feature.

FIG. 10 discloses how pins 761 are received within the tongue featuresof the anterior wall 753.

FIG. 11 discloses an embodiment of the present invention wherein thespacer comprises an anterior wall 753 connected to an integral body 759,wherein the integral body is substantially solid and comprises the twoside walls and a posterior wall, and is made of allogenic bone.

FIGS. 12A-C disclose an inserter tip 760 of the present invention. Theinserter tip comprises a proximal barrel 761 forming two distal tynes763. Each tyne has an attachment feature 765 for grabbing the implantand an annulus 767 for receiving a bone screw.

Eighth Aspect of the Invention

Conventional cervical cages are typically held in place by the use of aplate that is anchored into the adjacent vertebrae by screws. However,certain cervical intervertebral fusion cages have angled screw holesthat allow anchoring screws to enter the cage and anchor into thevertebrae without the use of a plate. These cages are often referred toas “stand alone” cages. Eliminating the plate beneficially results in alower-profile implant, fewer implant components, and a lower cost.However, it is important that the stand alone cage possess a screwretention mechanism that prevents the inserted screws from backing outof the cage, which may cause loosening of the cage or even perforationof the esophagus.

The present invention comprises a retaining element that retains theseanchoring screws within the cage. It preferably includes an additionalcomponent, namely a retaining plate 801, which is shown by itself inFIG. 13A. The retaining plate is slidably mounted on the anterior face803 of the cage, which is shown by itself in FIG. 13B. The assembly ofthe retaining plate upon the anterior face of the cage is shown in FIGS.13C and 13D. This plate can be slidably mounted to the cage usingconventional mounting mechanisms such as a dovetail or track. Theretaining plate comprises several through-holes 804—one for each screwhole 805 provided in the cage. The cage could be inserted with the plateholes misaligned with the holes of the cage. In this condition, theplate is in its “retain” or “closed” position. After insertion, theplate is translated into an “open” position whereby the holes in theplate are aligned with the holes in the cage, as in FIG. 13C. This isthe position for screw insertion. The anchor screws are then insertedthrough the aligned holes in the retaining plate and cage so that theyanchor the cage into the vertebrae. Finally, the plate is translatedinto its “retain” position (of FIG. 13D) so that the through-holes ofthe plate are again misaligned with the screw holes of the cage. Themisalignment of the screw holes prevents the screws from backing out ofthe cage.

Therefore, in accordance with the present invention, there is providedan intervertebral device for insertion into a disc space defined byopposing vertebral endplates, comprising:

-   i) an intervertebral spacer comprising:    -   a) an anterior wall having an upper surface and a lower surface,        an anterior surface, and a first hole extending from the        anterior surface to the upper surface and a second hole        extending from the anterior surface to the lower surface,    -   b) a posterior wall having an upper surface and a lower surface,        and    -   c) first and second side walls connecting the anterior and        posterior walls, each side wall having an upper surface and a        lower surface,-   ii) a first screw received in the first hole and having a distal    tip, an intermediate shaft having a first thread, and a proximal    head, and-   iii) a retaining plate slidably mounted to the anterior surface of    the spacer in a first and a second slidable position, the plate    having first and second holes,

wherein, in the first slidable position, the first hole of the platealigns with the first hole of the spacer to allow passage of the screwtherethrough, and

wherein, in the second slidable position, the first hole of the platemis-aligns with the first hole of the spacer to prevent back out of thescrew.

Additionally, mechanisms can be provided that prevent the plate frompost-operatively moving back to its initial open position. Some suchmechanisms direct engagement of components in the medial-lateraldirection (as in FIGS. 13C and 13D), while other direct engagement ofcomponents in the anterior-posterior direction.

In some embodiments, as in FIGS. 13A-D, a protrusion-type lockingfeature 811 on the anterior surface of the cage engages a mating recess813 on a locking arm 815 on the plate, thereby preventing the plate fromreturning to the “open” position. This locking mechanism could beprovided via a number of different embodiments, including features thatmove in a medial-lateral or anterior-posterior direction to produce thedesired locking.

For example, in a first (medial-lateral) embodiment, and now referringto FIGS. 13A-D, a protruding mating feature 811 provided on the anteriorface of the cage moves laterally to engage a recessed mating feature 813provided on the plate when the device is in its “retain” position,thereby preventing the plate from returning to the “open” position.Typically, one of these features is provided as a flexible orspring-like element so that the mating features snap into place, therebylocking the relative positions of the plate and cage. These matingfeatures can also be designed to index the plate between “open” and“retain” positions. In some embodiments thereof, the protrusion can beprovided at the end of a flexible arm that moves laterally across theplate to engage the recess. Alternatively, a recessed mating featureprovided on the anterior face of the cage could engage a protrudingmating feature provided on the plate when the device is in its “retain”position, again locking the relative positions of the plate.

In a second (anterior-posterior) embodiment, a moveable protrusion (suchas a ball detent) is mounted in the cage to move in the A/P directionand engage a recess in the plate, again indexing the plate in the twopositions. Alternatively, a locking arm cut into the locking plate witha deflection direction in the A/P direction could engage with a recesscut into the cage.

In one method of using the present invention, the plate-cage assembly isfirst loaded into the disc space. The insertion instrument used for cageinsertion and screw placement has an additional mechanism that laterallyslides the plate over the anterior surface of the cage. When the plateis slid into “open” position, screws are inserted therethrough. When theplate is then slid into “retain” position, the holes in the plate andcage mis-align, thereby preventing the screws from backing out.

Therefore, in some embodiments, the plate is slidable in amedial-lateral direction across the anterior face of the spacer, whilein others the plate is slidable in an upper-lower direction across theanterior face of the spacer.

In some embodiments, the spacer and plate include a locking feature toretain the holes in a mis-aligned state. Preferably, the locking featurecomprises a locking arm or a ball detent. In some embodiments, thelocking feature locks in a medial-lateral direction, while in others thelocking feature locks in an anterior-posterior direction, and in stillothers the locking feature locks in an upper-lower direction.

In some embodiments, the locking feature comprises a protrusion and arecess.

In another embodiment, and now referring to FIGS. 14A-15B, a sidewall821 of the retaining plate 823 is equipped with a living spring 825.This plate is adapted to slidably engage a pair of parallel rails (notshown) extending laterally across the anterior face of the cage. Thelateral movement of the plate is arrested by stop 826. The placement ofthrough-holes 827 on the plate is predetermined so that a) the platethrough-holes align with the screw holes 829 of the cage when the plateis biased so as to fully compress the spring (as in FIG. 14B), and b)the plate through-holes mis-align with the screw holes of the cage whenthe bias is released so as to allow expansion of the spring (as in FIG.15B).

FIG. 16 presents another embodiment of a plate 830 having a sidewall 831equipped with a “living spring” 833. The opposing sidewall 835 of theplate has a chamfer feature 837 that mates with a chamfered surface on agrabber instrument. In using this embodiment of FIG. 16, and nowreferring to FIG. 17, the device is typically installed with the platein its unbiased position. Prior to inserting screws into the cage,opposed jaws 841 of a grabber instrument are placed about the device tocontact the chamfered surface 837 of the plate and a sidewall 834 of thecage. The grabber instrument is then actuated so that its jaws 841 arecompressed so as to compress the spring 833. In this biased position,the holes are aligned and screws can be inserted therethrough into thecage. Upon insertion, the jaws of the grabber can be released so as torelease the bias from the spring and return the plate to its formerposition in which the holes are mis-aligned, thereby preventing screwbackout.

In other embodiments, the living spring is replaced with a stand-alonecompression spring or leaf spring.

In another embodiment, and now referring to FIG. 18, the plate may bealtered so as to eliminate the need for the grabber instrument discussedabove. In this embodiment, the through-holes 851 of the plate areprovided with unilateral chamfers 853 that mate with the distal tip 855of the screw being inserted. Continued insertion of the tip into thethrough-hole causes spring 861 to compress and plate 857 to slidelaterally, and thereby align the holes of the plate with the holes 859of the cage. Once the head of the screw passes the chamfered hole of theplate, the living spring component 861 of the plate expands so as tocause mis-alignment of the holes, thereby preventing screw back-out.

Therefore, in accordance with the present invention, the plate furthercomprises first and second sidewalls, wherein the first sidewallcomprises a living spring. In some embodiments thereof, the secondsidewall of the plate comprises a feature (preferably, a chamfer) formating with a grabber instrument. In other embodiments, the holes of theplate comprise chamfers adapted to mate with the distal tip of thescrew.

Ninth Aspect of the Invention

Prior art references related to a fixation cage with a secondary washerinclude: U.S. Patent Publication 2010-0057206; U.S. Patent Publication2009-0088849; U.S. Patent Publication 2010-0145459; U.S. Pat. Nos.6,730,127; 7,662,182; 6,972,019; U.S. Patent Publication 2008-0249569;U.S. Patent Publication 2009-0105831; U.S. Pat. Nos. 7,306,605;7,288,094; U.S. Patent Publication 2010-0312345; U.S. Patent Publication2010-0286777; U.S. Pat. No. 6,945,973; U.S. Patent Publication2010-0106249; U.S. Pat. Nos. 6,849,093; 6,984,234; U.S. PatentPublication 2009-0105830; U.S. Patent Publication 2009-0210062; U.S.Pat. Nos. 7,674,279; 7,452,370; 6,558,423; 6,890,335; 6,629,998.

Conventional fixation cages have several means for capturing angledbone-engaging screws and ensuring that those screws do not back out.Conventional anti-backout mechanisms include assembled rotating coverplates, cams, bushings, expanding screws, and set screws. One particularanti-backout means is a secondary cover plate that either snaps onto thecage itself or is docked to the cage and secured to the cage faceplateusing additional hardware, such as a screw. This secondary cover platecan fully or partially cover the most proximal portion of the screw headand could in theory prevent any screw backout.

As noted above, FIGS. 5C-E, supra, describe some embodiments utilizing aparticular anti-backout mechanism in which the proximal end portion ofthe screwthread has a parallel sidewall. Once the screw is threaded intoposition so that the entire threadform has passed over the ring, thedistal portion of the screw head proximally abuts the ring, therebypreventing further advance. In addition, if the screw were to beginbackout, the last turn of the screw thread (i.e., the proximal endportion of the thread having the parallel sidewall) would soon abutagainst the ring, thereby preventing backout.

In the present invention, the ring is replaced by a stand-alone washerpositioned anterior to the screw hole.

There is no known secondary washer and/or plate in the field of anteriorcervical fusion that attaches to the fixation screw (and not directly tothe cage). Such a washer could float approximately around the neck ofthe screw or be integral with the head of the screw. This washer wouldcover one or more of the other angled fixation screws, thus preventingscrew backout.

Thus, if a device possesses the above-discussed lag features in thescrew and the helical feature in the bore of the cage, the device mayfurther comprise a secondary washer. The purpose of the secondary washeris to further resist screw backout.

The secondary washer may preferably be loosely attached to the proximalshaft of a final fixation screw. The screw-washer combination is thelast item added to the cage construct to complete the device assembly.The washer is designed to float in a predetermined zone of the fixationscrew distal of the screw head, and ideally would be removed only withspecial equipment.

Therefore, and now referring to FIGS. 19A-C, 20 and 21, there isprovided an intervertebral device for insertion into a disc spacedefined by opposing vertebral endplates, comprising:

-   i) an intervertebral spacer 900 comprising:    -   a) having an anterior wall 901 having an upper surface 903 and a        lower surface 905, an anterior surface 907, and a first        screwhole 909 extending from the anterior surface to the upper        or lower surface of the anterior wall,    -   b) a posterior wall 911 having an upper surface 913 and a lower        surface 915, and    -   c) first and second side walls 917 connecting the anterior and        posterior walls, each side wall having an upper surface 919 and        a lower surface 921,-   ii) a first screw 923 received in the first screwhole and having a    distal tip 925, an intermediate shaft 927 having a first thread 929,    and a proximal head 931,-   iii) a washer 933 having a body portion 935, an aperture 937, a    proximal face 939 and a distal face 941, the washer positioned    anterior to the anterior face so that its aperture aligns with the    first screwhole;

wherein the shaft of the screw is received in the aperture of the distalwasher.

The washer is designed to seat on the anterior (proximal) face of theanterior wall of the cage, against the region of the wall surroundingthe corresponding screw-hole. It may be held in place by a snap clipfeature 951 and corresponding recess 953 residing on the upper or lowerface of the cage (shown in FIGS. 20 and 21).

In some embodiments, the washer further comprises design features thatabut corresponding features in the cage to ensure proper positioningupon final seating. In one such embodiment, as in FIG. 22, the peripheryof the washer has a contour 961 that matches and seats in a recess inthe anterior portion of the cage.

In some embodiments, the design features may resist washer rotation. Inone such embodiment, the distal face of the washer has at least oneprojection 963 that matches and seats in a corresponding recess in theanterior face of the cage.

In another embodiment, the proximal or distal face of the washer has atleast one projection 965 that serves to interrupt screw backout.

Also, in some embodiments, the washer comprises screw engagementfeatures. Upon the fixation screw's final rotation, the screw will passthrough the aperture in the washer at an angled trajectory. Features ofthe washer surrounding the aperture could engage features of the screwin its final degrees of rotation so as to prevent easy counter-clockwiseremoval of the screw.

When the washer is integral with the screw head, the head comprises atleast one flange (i.e., the washer) extending therefrom, the flangehaving a proximal face and a distal face.

We claim:
 1. An intervertebral fusion device comprising: i) anintervertebral cage including; a) upper and lower surfaces that arespaced from each other along a first direction and are configured toengage respective vertebral bodies; b) a proximal wall that defines aproximal surface; c) a distal wall opposite the proximal wall, and d)first and second side walls connected between the proximal and distalwalls, wherein the proximal surface defines a center that isequidistantly spaced from the first and second side walls; and ii) aplate that defines a through-hole extending therethrough, wherein theplate is slidable along the proximal surface of the intervertebral cagealong a direction of sliding that lies in a plane that is perpendicularto the first direction; and iii) a screw received by the through-hole ofthe plate, wherein the intervertebral cage defines a hole that extendsinto the proximal wall, and when the screw extends into the hole of theintervertebral cage, the plate is configured to be disposed in aposition whereby 1) the through-hole of the plate is offset in itsentirety from the center along the plane so as to define a gap betweenthe through-hole and the center along the plane, 2) a first portion ofthe hole is aligned with the through-hole of the plate, and 3) a secondportion of the hole is offset from the through-hole of the plate alongthe plane, the second portion of the hole being different than the firstportion of the hole, wherein the plane extends through both thethrough-hole of the plate and a central location of the hole of theintervertebral cage, the central location of the hole being centrallydisposed in the hole with respect to the first direction.
 2. Theintervertebral fusion device as recited in claim 1, wherein the proximaland distal walls are spaced from each other along a second directionperpendicular to the first direction, and the plate is slidable alongthe proximal surface of the intervertebral cage such that an opening tothe through-hole is movable from a first position to a second positionthat is offset with respect to the first position along a thirddirection that is perpendicular to each of the first and seconddirections, the opening disposed at a surface of the plate that facesthe proximal surface of the intervertebral cage.
 3. The intervertebralfusion device as recited in claim 1, wherein an opening to thethrough-hole defines a circle.
 4. The intervertebral fusion device asrecited in claim 3, wherein the plate is translatably coupled to theintervertebral cage via a track.
 5. The intervertebral fusion device asrecited in claim 4, wherein the track is linear.
 6. The intervertebralfusion device as recited in claim 1, wherein the plate retains the screwin the intervertebral cage.
 7. The intervertebral fusion device asrecited in claim 6, wherein the plate prevents the screw from backingout of the intervertebral cage.
 8. The intervertebral fusion device asrecited in claim 7, wherein the screw is elongate along a central axis,and a portion of the plate overlaps a portion of the screw along adirection that is parallel to the central axis, so as to prevent thescrew from backing out of the intervertebral cage.
 9. The intervertebralfusion device as recited in claim 8, wherein the screw defines a screwhead and a distal tip spaced from the screw head along the central axis,and the portion of the plate defines a surface that is disposed betweenthe distal tip of the screw and the proximal surface with respect to thedirection that is parallel to the central axis.
 10. The intervertebralfusion device as recited in claim 1, wherein the screw is configured toengage an instrument that is received by the through-hole, so as todrive the screw to rotate.
 11. The intervertebral fusion device asrecited in claim 1, wherein the screw is externally threaded.
 12. Theintervertebral fusion device as recited in claim 1, wherein each of theupper and lower surfaces define teeth configured to grip the respectivevertebral bodies.
 13. The intervertebral fusion device as recited inclaim 1, wherein the proximal and distal walls are spaced from eachother along a second direction perpendicular to the first direction, theplate is slidable along the proximal surface of the intervertebral cagesuch that the second portion of the hole is offset with respect to thethrough-hole along a third direction that is perpendicular to each ofthe first and second directions.
 14. The intervertebral fusion device asrecited in claim 1, wherein a cross-section of the through-hole definesa circle.
 15. The intervertebral fusion device as recited in claim 1,wherein the plane further passes through a central location of thethrough-hole of plate, the central location of the through-hole beingcentrally disposed with respect to the first direction.
 16. Theintervertebral fusion device as recited in claim 1, wherein thethrough-hole of the plate has a perimeter that is enclosed by the plate.17. An assembly comprising: the intervertebral fusion device as recitedin claim 1; and a second screw, the second screw having a threaded shaftconfigured to be driven into one of the upper and lower vertebralbodies.
 18. The assembly as recited in claim 17, further comprising athird screw, the third screw having a threaded shaft configured to bedriven into one of the upper and lower vertebral bodies.
 19. Anintervertebral fusion device comprising: i) an intervertebral cageincluding; a) a proximal wall that defines a proximal surface thatextends from a first side of the intervertebral cage to a second side ofthe intervertebral cage such that the proximal surface defines a centerthat is equidistantly spaced from the first and second sides of theintervertebral cage, wherein the intervertebral cage defines a hole thatextends into the proximal wall, the hole has an opening at the proximalsurface, and the proximal surface defines a fully enclosed perimeter ofthe opening; b) a distal wall opposite the proximal wall, c) first andsecond side walls disposed at the first and second sides, respectively,and connected between the proximal and distal walls; and d) upper andlower surfaces that are spaced from each other along a first directionand are configured to engage respective upper and lower vertebral bodiesthat define the intervertebral space; and ii) a plate that defines athrough-hole extending therethrough, wherein the through-hole is fullyenclosed by a perimeter, an entirety of the perimeter is defined by theplate, and the plate is slidable along the proximal surface of theintervertebral cage along a direction of sliding that lies in a planethat is perpendicular to the first direction; and iii) a screw receivedby the through-hole of the plate along a screw direction, wherein theintervertebral fusion device is configured to be fully implanted in anintervertebral space such that 1) the through-hole of the plate isoffset in its entirety from the center, 2) a first portion of the holeis aligned with the through-hole of the plate along the screw direction,and 3) a second portion of the hole is offset from the through-hole ofthe plate along the direction of sliding, the second portion of the holebeing different than the first portion of the hole, and wherein theplane extends through both the through-hole of the plate and a centrallocation of the hole of the intervertebral cage, the central location ofthe hole being centrally disposed in the hole with respect to the firstdirection.
 20. The intervertebral fusion device as recited in claim 19,wherein the proximal and distal walls are spaced from each other along asecond direction perpendicular to the first direction, and the plate isslidable along the proximal surface of the intervertebral cage such thatan opening to the through-hole is movable from a first position to asecond position that is offset with respect to the first position alonga third direction that is perpendicular to each of the first and seconddirections, the opening to the through-hole disposed at a surface of theplate that faces the proximal surface of the intervertebral cage. 21.The intervertebral fusion device as recited in claim 19, wherein anopening to the through-hole defines a circle.
 22. The intervertebralfusion device as recited in claim 21, wherein the plate is translatablycoupled to the intervertebral cage via a track.
 23. The intervertebralfusion device as recited in claim 22, wherein the track is linear. 24.The intervertebral fusion device as recited in claim 19, wherein theplate retains the screw in the intervertebral cage.
 25. Theintervertebral fusion device as recited in claim 24, wherein the plateprevents the screw from backing out of the intervertebral cage.
 26. Theintervertebral fusion device as recited in claim 25, wherein the screwis elongate along a central axis, and a portion of the plate overlaps aportion of the screw along a direction that is parallel to the centralaxis, so as to prevent the screw from backing out of the intervertebralcage.
 27. The intervertebral fusion device as recited in claim 19,wherein the screw is configured to engage an instrument that is receivedby the through-hole, so as to drive the screw to rotate.
 28. Theintervertebral fusion device as recited in claim 19, wherein the screwis externally threaded.
 29. The intervertebral fusion device as recitedin claim 19, wherein the proximal and distal walls are spaced from eachother along a second direction perpendicular to the first direction, theplate is slidable along the proximal surface of the intervertebral cagesuch that the second portion of the hole is offset with respect to thethrough-hole along a third direction that is perpendicular to each ofthe first and second directions.
 30. The intervertebral fusion device asrecited in claim 19, wherein the screw is further received in the holeof the intervertebral cage.
 31. The intervertebral fusion device asrecited in claim 19, wherein a cross-section of the through-hole definesa circle.
 32. An assembly comprising: the intervertebral fusion deviceas recited in claim 19; and a second screw, the second screw having athreaded shaft configured to be driven into one of the upper and lowervertebral bodies.
 33. The assembly as recited in claim 32, furthercomprising a third screw, the third screw having a threaded shaftconfigured to be driven into one of the upper and lower vertebra.